Process Engineer/Senior Process Engineer

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio! AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics. The AmplifyBio ecosystem is comprised of two distinct business units: ASET (West Jefferson, OH) ABio's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) ABio's Manufacturing Enablement Center. About AMEC New Albany, OH: AmplifyBio's Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a hoteling model, traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages. AmplifyBio is seeking to hire a Process Engineer/Senior Process Engineer to join our Manufacturing Science and Technology (MSAT) team!!! This role will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives. The Process Engineer will be hands-on with the manufacturing operations, facilities, and equipment. Once the process and equipment are implemented, this position will support the manufacturing operations within the AmplifyBio GMP facility. The role will provide technical expertise to manage manufacturing and support the technical transfer of processes into the multi-use facility. The Process Engineer/Snr. Process Engineer will have hands-on experience with cGMP cell and/or gene therapy manufacturing and implementation of new processes into GMP facilities and will support the completion of all goals and objectives of manufacturing. It is expected that this position will work closely with other internal functional departments as well as external clientele to ensure deliverables are met. What You'll Do Here: Responsible for managing the transfer of CGT manufacturing processes from our clients into the AmplifyBio GMP facility. Provide leadership and training of the manufacturing staff on cell and gene manufacturing processes and equipment. Support the manufacturing staff during technical transfer, start up and in routine processing. Works effectively with the other operational groups to ensure that all GMP requirements are met for the implementation of processes into the AmplifyBio facility. Works closely with the Supply Chain, Quality Control, Validation, Engineering, and Quality Assurance functions internally to ensure the facility meets all appropriate standards and cell therapy manufacturing processes are performed per client and GMP requirements. Coordinates Manufacturing timelines and deliverables through Joint Project Teams, Program Management, and other functions as appropriate. Provides support during facility start-up and activities associated with future expansions. Provide support on equipment implementation and qualification. Author and reviews relevant documentation for cell manufacturing operations and equipment. Position may require some travel. We Would Love to Hear from You If: BS, MS, or PhD degree in engineering or scientific field plus at least 6 years of experience. Minimum of 6+ years of experience in Manufacturing or Development roles with more than 2 years in a drug product development and manufacturing function at a biotechnology or pharmaceutical company with direct involvement in the process to achieve early development milestones and successful product licensure. Knowledge and experience in transferring a process into a new facility (such as from Process Development, CMO, or Manufacturing). Experience with aseptic processing, cell and/or gene therapy manufacturing. Experience in leading meetings, teams, and projects. Experience with issues related to manufacturing is required. Knowledge of current requirements for cGMPs required and knowledge of GLP/GTP/GCP is a plus. Forward-thinking and creative with high ethical standards. Team player with leadership skills with ability to influence others to achieve successful manufacturing campaigns and to enable regulatory product approvals. Well organized and self-directed. Strong interpersonal skills with an ability to communicate to people at all levels of an organization. Highly Desired: Direct hands-on experience in Cell and Gene Therapy, mRNA/LNP manufacturing, tech transfer, or process development. At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization. AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law. Why You Will Love Working Here: We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own. Health, Dental, and Vision insurance that starts on your first day at AmplifyBio! Competitive Compensation Package We take work-life balance seriously and we back it up with a flexible PTO policy. Generous paid parental leave Wellness and Self-Care Programs 401(k) match Tuition Reimbursement Employee mentoring and recognition programs EAP/work-life support system A fun work environment where everyone's voice matters. We are just getting started! More benefits on the way! An Opportunity to Change the World!!! When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees. PI270669bcd0b2-26289-37094705

Created: 2025-03-10